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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameELECSYS FREE PSA (FPSA) TEST SYSTEM
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP000027
Supplement NumberS012
Date Received08/01/2011
Decision Date02/24/2012
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extension of the elecsys free psa (fpsa) test system onto the cobas e 602 immunoassay analyzer.
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